The Journal of surgical research · 2025
Polidocanol Retention Therapy for Benign Predominantly Cystic Thyroid Nodules: Analysis of Efficacy, Safety, and Factors Influencing Short-Term Efficacy: A Single-Center Exploratory Study.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Chen Lijie, Wang Xiqian, Liu Yafei, Zhang Wei, Zhang Rui, Cai Ranglamu, Zhang Jie
Аннотация
INTRODUCTION: Ultrasound-guided chemical ablation is a first-line treatment for benign cystic thyroid nodules. Although absolute ethanol is the most common sclerosing agent, it is associated with prolonged procedure time and potential complications. Polidocanol, a widely used sclerosing agent for varicose veins, liver, and kidney cysts, offers a potential alternative due to its favorable safety profile. This study aimed to compare the efficacy and safety of polidocanol retention versus absolute ethanol lavage and identify factors predicting treatment success.
METHODS: This two-part investigation consisted of a prospective randomized exploratory study (part 1; n = 68) and a retrospective predictor analysis (part 2; n = 76). In part 1, patients were randomly assigned to undergo either absolute ethanol lavage (ethanol group, n = 34) or low-dose polidocanol retention (polidocanol group, n = 34). The primary endpoint was the volume reduction rate of the thyroid nodules at 3 mo. Secondary outcomes included rates of complications and operation procedure. Part two combined patients from the polidocanol group of the part 1 with additional retrospectively reviewed cases to identify predictors of treatment response, with a specific focus on baseline nodule volume and thyroglobulin (Tg) levels in the lavage fluid.
RESULTS: In the first part, both groups achieved significant volume reduction at 3 mo (ethanol: 92.78% versus polidocanol: 83.51%, P > 0.05). The polidocanol group had a numerically lower complication rate (2.9% versus 8.2%, P = 0.64). In the second part, lavage fluid Tg ≤ 310 ng/mL was a strong predictor of treatment success at 3 mo (area under the curve = 0.885, sensitivity = 84.48%, specificity = 91.27%).
CONCLUSIONS: Polidocanol demonstrated noninferior efficacy to ethanol, achieving comparable volume reduction while offering a simplified treatment protocol and a more favorable safety profile. Baseline nodule volume and lavage fluid Tg are key predictors of short-term efficacy.
METHODS: This two-part investigation consisted of a prospective randomized exploratory study (part 1; n = 68) and a retrospective predictor analysis (part 2; n = 76). In part 1, patients were randomly assigned to undergo either absolute ethanol lavage (ethanol group, n = 34) or low-dose polidocanol retention (polidocanol group, n = 34). The primary endpoint was the volume reduction rate of the thyroid nodules at 3 mo. Secondary outcomes included rates of complications and operation procedure. Part two combined patients from the polidocanol group of the part 1 with additional retrospectively reviewed cases to identify predictors of treatment response, with a specific focus on baseline nodule volume and thyroglobulin (Tg) levels in the lavage fluid.
RESULTS: In the first part, both groups achieved significant volume reduction at 3 mo (ethanol: 92.78% versus polidocanol: 83.51%, P > 0.05). The polidocanol group had a numerically lower complication rate (2.9% versus 8.2%, P = 0.64). In the second part, lavage fluid Tg ≤ 310 ng/mL was a strong predictor of treatment success at 3 mo (area under the curve = 0.885, sensitivity = 84.48%, specificity = 91.27%).
CONCLUSIONS: Polidocanol demonstrated noninferior efficacy to ethanol, achieving comparable volume reduction while offering a simplified treatment protocol and a more favorable safety profile. Baseline nodule volume and lavage fluid Tg are key predictors of short-term efficacy.